A specialty CRO serving pharmaceutical, biopharmaceutical & medical device companies.  
Making Strategic Moves
  • Adaptive Design
  • Bayesian and Frequentist Analysis
  • Phase I to Phase IV Trials
  • Device Trials
  • Sample Size Calculations
  • Randomizations
  • Statistical Analysis Plan



  • Custom Reporting
  • SDTM and ADaM Datasets
  • CDISC Conversions
  • CRF Design/Review
  • AE Coding
  • Paper-based DM
  • EDC Study Management





  • Direct FDA interaction and presenting at panel meetings
  • Experience in multiple therapeutic areas
  • Device Submission Support; PMA,NDA and 510k
  • Bayesian and Frequentist methods resulting in regulatory approvals
  • Adaptive trial design proficiency and experience

05/07/2014 - the Southeastern Medical Device Association, 8th annual conference Atlanta, GA May 7th-8th
5/13/2014 - Outsourcing in Clinical Trials East Coast, Philadelphia, PA May 13th-14th
6/2/2014 - Partnerships in Medical Device Trials, Chicago, IL June 2nd-4th
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  Biostatistics Consulting & Analysis - Clinical Data Management. Programming Solutions. Report Production.Regulatory Support.  
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